ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Assurance Issues
Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (infection) from a sterile medical device where sterility is not assured, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes (Part number: 8900-4013). These disposable, single-use electrodes are used in connection with ZOLL Defibrillators for adult patients to provide defibrillation, cardioversion, external non-invasive pacing, and monitoring. The affected units are identified by Lot Number 2314.
The recall was initiated because the sterility of the device is not assured. The product is intended for use in a sterile environment by trained medical professionals and is processed through Gamma Radiation to a Sterility Assurance Level (SAL) of 10^-6 per international and national standards.
The affected product was distributed worldwide, including nationwide in the United States and internationally to Australia, Canada, and Germany. Consumers and healthcare providers should stop using the affected lot and contact the recalling firm for further instructions.
The recalled product
- Product
- ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per…
- Manufacturer
- Bio-Detek, Inc.
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 2314
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Bio-Detek, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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